Rhythm Pharmaceuticals Inc Rhythm Pharmaceuticals (RYTM) is a late-stage biopharmaceutical company with a product pipeline that reflects its focus of developing treatments for rare genetic obesity. The firm’s lead product, setmelanotide, is a melanocortin-4 receptor (MC4R) agonist being developed for severe obesity and hyperphagia associated with rare genetic obesity. The United States FDA has accepted Rhythm’s . . . This content is for paid subscribers. Please …

Moderna Presented Interim Clinical Data about mRNA-1273 for COVID-19 Moderna (MRNA) presented new Interim Clinical Data about . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

CureVac is Publicy Trading on the NASDAQ CureVac is now publicly trading on the NASDAQ stock exchange with the symbol CVAC, as of August 14, 2020. We assume you must have heard the name of this firm by now and of America’s attempts to buy it for its messenger ribonucleic acid (mRNA) approach. This approach creates vaccines and drugs inside the living bodies. CureVac (CVAC) mRNA-derived …

Intellia Therapeutics  Reporting operational highlights and financial results for the second quarter ended June 30, 2020, Intellia Therapeutics (NTLA) announced its first Clinical Trial Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1 study of NTLA-2001 for transthyretin . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Seres Therapeutics Oral Microbiome Product SER-109 for Recurrent C. Difficile Infection Meets Trial Endpoint SER-109 demonstrated a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo. Efficacy results Support BLA filing as a single pivotal trial. The Company will meet with the FDA to discuss filing for product approval as soon as possible. Positive SER-109 Phase 3 …

Compugen Compugen (CGEN) cancer immunotherapy’s predictive target computational discovery platforms enabled it to identify two checkpoint proteins, PVRIG and TIGIT, when nobody else could. Compugen’s technological capability has also enabled it to create therapeutic inhibitors of its two discovered targets. The discoveries happened to be important in improving cancer immunotherapy. The lead therapeutic candidate, COM701 . . . This content is for paid subscribers. Please …

SARS-CoV-2 Virus Vaccines Moderna On Monday Moderna (MRNA) started its Phase 3 clinical trial on 30,000 people with its product mRNA-1273. Separately, in a press release Moderna announced a preclinical study evaluating its product mRNA-1273 has been published in The New England Journal of Medicine. This study . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Beyond the firms that are speeding towards bringing prophylactic vaccines against the COVID-19 infection into the clinic we have to consider the other firms that have been negatively affected by the virus pandemic; we expect them to rebound and surge when the virus loses its ability to kill. We decided to start with gene therapy companies that we believe have suffered from the delays of …

CRiSPR Therapeutics Rally  For those who wonder why CRiSPR Therapeutics (CRSP) is soaring we remind that they should have been expecting this rally and for it to be followed by its two sisters Intellia Therapeutics (

Akero Therapeutics Today we posted good news from Akero Therapeutics (AKRO) under News & Comments. The news was about results from Phase 2a BALANCED . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Unclear Reasoning for the Inovio Selloff Though Inovio (INO) announced positive interim clinical data of INO-4800 (its vaccine candidate against novel coronavirus (SARS-CoV-2)) from the first of two Phase 1 clinical trial cohorts, the stock still fell around 11%. The reason for the selloff is still unclear to us. Some have said the reason for the stock . . . This content is for paid …

Novel Coronavirus Vaccines and Wall Street Vaccines against novel coronavirus are recognized now as the only way to return disrupted human lives back to normal. Vaccines have become the most important topic for Wall Street’s investors and analysts especially at times when the virus demonstrates its capability to continue disrupting human lives on the entire planet. Betting up and down on the firms that are …

Inovio Received US DoD Funding for CELLECTRA® 3PSP Smart Device Inovio (INO) announced today it has received $71 million in funding from the U.S. Department of Defense (DoD) to support the large-scale manufacture of the company's proprietary CELLECTRA® 3PSP smart device and the procurement of CELLECTRA® 2000 devices. CELLECTRA® 3PSP was created to deliver the INO-4800 . . . This content is for paid subscribers. …

Good News for Jazz, Celldex, Inventiva & Illumina Jazz Pharmaceuticals Good News Jazz Pharmaceuticals (JAZZ) announced along with its partner PharmaMar (MSE: PHM) that the U.S. FDA has approved Zepzelca™ (lurbinectedin) for adults with metastatic small cell lung cancer (SCLC) and disease progression on or after platinum-based chemotherapy.  Zepzelca was granted accelerated approval based on the overall response rate (ORR) and duration of response. <Continued approval for this indication may be contingent upon verification and …

Illumina Diagnostic Test COVIDSeq to Detect SARS-CoV-2 Illumina (ILMN) was issued an Emergency Use Authorization (EUA) from the FDA for the first COVID-19 diagnostic test utilizing next-generation sequence technology. The authorization was granted for the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected . . . This content is for paid subscribers. Please click here to subscribe …

Moderna mRNA-1273 Vaccine for COVID-19  The market is expected to open DOWN today. Moderna’s (MRNA) stock price, however, is expected to post gains as news coming from the company is highly encouraging. Moderna announced progress on the late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19. Based on feedback from the . . . This content is for paid subscribers. Please click here to …

Myovant Sciences Good News A lot of positive news is emanating from clinical trials conducted by development-stage biotechnology firms and revenue-generating firms. The good news in the small development-stage firms becomes more interesting when the trial results are from Phase 3 trials and other late Phase trials. The cancer news that attracted the attention of the specialists and analysts who followed up on the presentations made …

Compugen IND Application for Triple Combination Study Cleared by the US FDA The U.S. Food and Drug Administration has cleared Compugen’s (CGEN) investigational new drug (IND) application for its Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, OPDIVO® (nivolumab) -- Bristol Myers . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Inovio DNA Vaccine Candidate INO-4800 for SARS-CoV-2 Inovio (INO) announced the publication of the preclinical study data for its novel coronavirus SARS-CoV-2 DNA vaccine INO-4800 which is demonstrating robust neutralizing antibody and T cell immune responses against COVID-19. The study was published in the peer-reviewed journal Nature Communications titled, "Immunogenicity of a . . . This content is for paid subscribers. Please click here to subscribe …

Novavax Still Rallying After Grant The Grant That Continues To Rally the Stock Novavax (NVAX) stock continues its ascent following yesterday's announcement that the firm was granted up to $384 million by the coalition for Epidemic Preparedness innovation. We remind that the grant is to help the advancement in the clinical development of the firm’s SARS-CoV-2 (